Senior Process Engineer

Cochlear; Sydney; On-site; AUD 150,000 - 190,000; Full time

Job summary

Cochlear is seeking a Senior Process Engineer to drive advanced automation within a regulated manufacturing environment in NSW. The role will lead deployment projects, develop ERS, and oversee IQ/OQ/PQ validation while improving yield and process controls.

Collaboration with vendors on robotics and machine vision will be essential, with involvement in NPI and technology transfer. The position requires a Bachelor’s in Mechatronics or related field and 3–5 years in regulated manufacturing,

Qualifications

• Bachelor's degree in Mechatronics Engineering or related engineering discipline is required.
• 3–5 years' experience in a regulated manufacturing environment (medical devices, pharmaceuticals, diagnostics, aerospace, or semiconductor).
• Experience leading automation deployment projects into production environments.
• Hands-on experience in process validation (IQ/OQ/PQ).
• Experience developing Engineering Requirement Specifications (ERS).
• Strong understanding of PFMEA and process controls.
• Experience delivering process improvements and data-driven yield optimisation.
• Strong stakeholder management across teams and external partners.

Responsibilities

• Lead automation deployment projects from design through production implementation.
• Develop equipment and process requirements, including ERS.
• Execute and support process validation activities (IQ/OQ/PQ).
• Drive yield improvement through data analysis, optimisation and risk management.
• Collaborate with automation vendors on robotics and machine vision solutions.
• Support NPI, technology transfer and continuous improvement initiatives.

Skills

Process validation

ERS development

Automation deployment leadership

PFMEA & risk management

Data analysis

Stakeholder management

Python scripting

Machine vision & robotics

Education

Bachelor's degree in Mechatronics Engineering or related engineering

Tools

PLC

HMI

Machine vision systems

Job description

The Opportunity

Cochlear has an opportunity for a full-time Senior Process Engineer based in our Macquarie University, NSW office. In this role, the successful Senior Process Engineer will provide specialised process engineering expertise to support the development, implementation and deployment of custom automation solutions within a regulated manufacturing environment. Working closely with automation partners and cross-functional stakeholders, this role will lead process improvements, support new technology introduction activities, drive validation programs and ensure manufacturing processes are capable, compliant and scalable.

Responsibilities include:

• Lead automation deployment projects from design through to production implementation.
• Develop equipment and process requirements, including Engineering Requirement Specifications (ERS).
• Execute and support process validation activities, including IQ, OQ and PQ protocols.
• Drive yield improvement initiatives through data analysis, process optimisation and risk management.
• Collaborate with automation vendors and internal stakeholders on robotics and machine vision solutions.
• Support new product introduction (NPI), technology transfer and continuous improvement activities.

What makes this opportunity unique?

This role sits at the intersection of process engineering and advanced automation, providing the opportunity to work with robotics, machine vision and custom manufacturing technologies that directly support the production of life-changing hearing solutions. You'll have the opportunity to influence manufacturing strategy, partner with leading automation suppliers and drive innovation within a highly regulated medical device environment.

About You.

As we grow our operations, we are looking for people who share our passion for delivering quality hearing solutions to our customers. To add value to Cochlear in this role, you'll be able to demonstrate the following skills and experience:

Essential:

• Bachelor's degree in Mechatronics Engineering or a related engineering discipline.
• 3-5 years' experience within a regulated manufacturing environment, such as medical devices, pharmaceuticals, diagnostics, aerospace or semiconductor industries.
• Demonstrated experience leading automation deployment projects into production environments.
• Hands-on experience in process validation, including IQ, OQ and PQ execution.
• Experience developing Engineering Requirement Specifications (ERS) and translating business requirements into technical solutions.
• Strong understanding of risk management methodologies, including PFMEA and process controls.
• Experience delivering process improvements, yield optimisation and statistical analysis.
• Strong stakeholder management skills with the ability to work effectively across teams and with external automation partners.

Ideal:

• Experience with industrial robotics implementation and automated manufacturing systems.
• Knowledge of machine vision systems and equipment characterisation.
• Experience participating in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).
• Familiarity with PLC and HMI-based control systems.
• Exposure to technology transfer and new product introduction (NPI) activities.
• Basic scripting capability in Python, Lua or similar languages.
• Experience coaching or mentoring junior engineers and graduates.

#CochlearCareers

How we recognise your contribution

At Cochlear we value and welcome the unique contributions, perspectives, experiences, and backgrounds of our employees and aim to build a culture that celebrates and leverages these differences, creating a sense of belonging and enabling our people to realise their full potential. Through our internal programs and employee benefits, we aim to create an environment where our people will feel value and supported. Whether your focus is on continuous learning, professional development or simply finding an environment which enables you to thrive whilst balancing family or personal life commitments, then we have several programs in place to support you.

For more information about Life at Cochlear, visit www.cochlearcareers.com